BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URISYS 2400

    MDR report key: 1437735 · Received April 15, 2009

    Report

    Report Number
    1823260-2009-02731
    Event Type
    Malfunction
    Date Received
    April 15, 2009
    Date of Event
    March 20, 2009
    Report Date
    April 15, 2009
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JIO
    PMA / PMN Number
    K012397
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO VERIFY THE PROBLEM, HE NOTED A PROBLEM WITH THE CALIBRATION AS A CAUSE. HE VERIFIED DEFAULT SETTINGS FOR REFLECTANCE, PERFORMED A CALIBRATION AND RAN CONTROLS TO VERIFY ANALYZER PERFORMANCE.

    Description of Event or Problem · 1

    USER EXPERIENCED TWO PT SAMPLES WHICH GENERATED RESULTS FOR ERYTHROCYTES FROM THE ANALYZER THAT DID NOT COMPARE WITH RESULTS FROM THE MICROSCOPIC EXAMINATION. THE FOLLOWING PT SAMPLE WAS DETERMINED TO BE DISCREPANT. INITIAL ERYTHROCYTE RESULT FROM ANALYZER WAS NEGATIVE. MICROSCOPIC EXAMINATION OF THE SAME URINE SAMPLE SHOWED 5 TO 10 RBCS PER HPF. SAMPLE WAS REPEATED ON THE ANALYZER GENERATING A NEGATIVE RESULT FOR ERYTHROCYTES. BOTH DIPSTICK AND MICROSCOPIC RESULTS WERE REPORTED FOR THIS PT SAMPLE. USER STATES THE PT WOULD NOT HAVE BEEN TREATED FOR THE NEGATIVE RESULT THAT WAS REPORTED ON THE DIPSTICK. THE USER DID NOT HAVE INFO AS TO WHETHER THE PT WAS ADVERSELY AFFECTED BY NOT RECEIVING TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 URISYS 2400 AUTOMATED URINE ANALYZER - JIL JIO ROCHE DIAGNOSTICS U2400

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK